- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743247
Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
April 14, 2016 updated by: Yon Su Kim, Seoul National University Hospital
Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation.
Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug monitoring with dose adjustment is required.
Investigating pharmacokinetic interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction between two drugs is still not well understood.
Therefore, an open-label, three period, single dose trial is planned to investigate the drug interaction between tacrolimus and mycophenolate mofetil.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg.
All subjects have one week of washing period between single dose administration.
Blood samples are drawn up to 72 hours after drug administration.
Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated.
Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male adult with age of 19-45
- Weight difference between ideal and actual body weight is less than 20%
- Previous healthy with no known disease
- Considered normal on physical exam, clinical laboratory tests(complete blood count, electrolyte, renal and hepatic function) and electrocardiogram
- Never been heavy-drinker within one month prior to trial initiation and able to abstain from alcohol during trial
Exclusion Criteria:
- Ever smoked within one year prior to trial initiation
- Took other drugs (including herbal medicine) within one month prior to trial initiation
- Alcohol or drug abuser
- Participated another clinical trial within three months
- Considered inadequate under investigator's discretion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus and Mycophenolate mofetil
Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
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0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak Concentration of Tacrolimus and Mycophenolate mofetil
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
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0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
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Adverse Drug Reaction
Time Frame: through study completion, an average of 1 month
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through study completion, an average of 1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yon Su Kim, M.D., Ph.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
December 18, 2015
First Submitted That Met QC Criteria
April 14, 2016
First Posted (Estimate)
April 19, 2016
Study Record Updates
Last Update Posted (Estimate)
April 19, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- 17-2015-006-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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